How to define and demonstrate medical device product claims?

With clinical specialist and entrepreneur, Helene Quie

What is this class about?

We will walk through the process of identifying your claims for your product, which data are needed and what specific methods to choose?
This class will be hosted on Team and the link will be emailed to you after your registration and payment.

Why should I attend?

In the Medical Device Regulation, the wording describing the use of claims has been strengthen. We will present to you:
·      What is a claim
·      The general regulation behind the use of claims
·      Where are claims used in the technical documentation?
·      What evidence are applicable to support certain claims?
·      How to keep control of the use of claims and get alignment in the team.
·      Tips and tricks on what Notified Body is looking for!

This Lecture will be held on
Tuesday, 6th April at 3:00 PM CET

Course Curriculum

  Lecture 5
Available in days
days after you enroll

Hi, I’m Helene Quie

Co-founder of Qmed Academy and senior advisor. I have 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.

Select a pricing plan and sign up